Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

NCT ID: NCT01012440

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-05-31

Brief Summary

The purpose of this study is:

1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer?

2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.

Detailed Description

Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Beast cancer subjects

Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods

Group Type: EXPERIMENTAL

PEM Flex Solo II PET Scanner

Intervention Type: DEVICE

Subjects will receive bilateral (both sides) breast and axillary PEM scans.

MRI scan

Intervention Type: DEVICE

Subjects will receive bilateral (both sides) breast and axillary MRI scans.

Interventions

PEM Flex Solo II PET Scanner

Subjects will receive bilateral (both sides) breast and axillary PEM scans.

Intervention Type: DEVICE

MRI scan

Subjects will receive bilateral (both sides) breast and axillary MRI scans.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy)

Exclusion Criteria

• Children (< 18 years old)
• Pregnant or Lactating women
• Diabetic patients (Type I or II)
• Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
• Patients who have NOT undergone a standard of care bilateral breast MRI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirti Kulkarni, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Chicago Medical Center

Locations

The University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

16895A

Identifier Type: -

Identifier Source: org_study_id